Alopecia AreataPhase 3NCT05041803

European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

A Phase 3 study testing CTP-543 in people with Alopecia Areata, run by Sun Pharmaceutical Industries, Inc. at 39 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Alopecia Areata
What is being tested?: CTP-543
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 407 participants
Where: 39 sitesin 5 countries
Study dates: 19 Oct 2021to 18 Jul 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Who cannot join

Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
Donation of blood at any point throughout the study and for 30 days after last dose of study medication

Trial locations and contacts

39 sites in 5 countries.

Country

City, postcode or hospital

39 sites in 5 countries

Poland14 sites

NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
Bialystok, 15-453
Vita Longa Sp.Zo.O
Katowice, 40-748
Specjalistyczny Gabinet Dermatologiczny s.c.
Krakow, 30-002
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100
ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110
ETG Skierniewice
Skierniewice, Masovian Voivodeship, 96-100
RCMed Oddzial w Sochaczewie
Sochaczew, Masovian Voivodeship, 96-500
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-500
OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o
Warsaw, Masovian Voivodeship, 00-716
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, Masovian Voivodeship, 02-661
ETG Warszawa
Warsaw, Masovian Voivodeship, 02-793
My Clinic
Warsaw, 00-144
Royalderm Agnieszka Nawrocka
Warsaw, 02-962
WroMedica I. Bielicka, A. Strazalkowska s.c.
Wroclaw, 51-685

Other trials in Poland

France8 sites

CHU de Bordeaux, Hopital Saint-Andre
Bordeaux, 33000
Service de Dermatologie CHRU de Brest - Hopital Morvan
Brest, Finistere, 29609
Hopital Saint-Louis - GH De La Rochelle-Re-Aunis
La Rochelle, 17019
Hôpital La Timone-Dermatologie
Marseille, 13385
Hopital de l'Hotel Dieu - CHU de Nantes
Nantes, 22093
Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2
Nice, Provence-Alpes-Côte d'Azur Region, 06202
Hôpital Saint Louis, Centre de Santé Sabouraud
Paris, 75010
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31059

Other trials in France

Germany7 sites

Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455
Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
Berlin, 10117
Universitätsklinikum Erlangen, Hautklinik
Erlangen, Bavaria, 91054
Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt am Main, Hesse, 60590
Klinikum Rechts der Isar, Technische Universität München, Hautklinik
München, Bavaria, 80802
Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)
Münster, North Rhine-Westphalia, 48149
Universitätsklinikum Tübingen Universitäts-Hautklinik
Tübingen, Baden-Wüttermberg, 72076

Other trials in Germany

Spain7 sites

Hospital Clínic de Barcelona
Barcelona, Barcelona/Cataluña, 08036
Hospital del Mar
Barcelona, 08003
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046

Other trials in Spain

Hungary3 sites

Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika
Budapest, Pest County, 1085
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika
Pécs, Baranya, 7632
SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrad-Csanad County, 6720

Other trials in Hungary

About this study

Official title: A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Conditions: Alopecia Areata
Being tested: CTP-543
Medical subject headings: Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTP-543Drug
Twice daily dosing

Study groups in NCT05041803
Study group	Role	What they receive
CTP-543	Experimental	Patients who previously completed a qualifying CTP-543 clinical trial Receives: Drug: CTP-543

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events as a Measure of Safety
Measured: 108 weeks
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100*(post-baseline value - baseline)/baseline.
Measured: 108 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202118 Jul 2024

First posted13 Sep 2021
Study start19 Oct 2021
Primary completion18 Jul 2024
Study completion18 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alopecia AreataStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 407 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05041803
Sponsor's protocol ID: CP543.5002
Other IDs: 2021-002365-18
Status last verified: Nov 2025
First submitted: 3 Sep 2021
Last updated: 21 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata

All Alopecia Areata trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
ClinicalTrials.gov ID: NCT05041803
Acronym / sponsor ID: CP543.5002
Conditions: Alopecia Areata
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 407 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Study start: 19 Oct 2021 (actual)
Primary completion: 18 Jul 2024 (actual)
Study completion: 18 Jul 2024 (actual)
First posted: 13 Sep 2021 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CTP-543	Experimental	Drug: CTP-543Patients who previously completed a qualifying CTP-543 clinical trial

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Key exclusion criteria (3 listed)

Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
Donation of blood at any point throughout the study and for 30 days after last dose of study medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CTP-543Twice daily dosing	Drug	CTP-543

Primary outcome

Number of Participants With Adverse Events as a Measure of Safety
Time frame: 108 weeks
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108
Time frame: 108 weeks
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100*(post-baseline value - baseline)/baseline.

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CTP-543 8 mg BID	255	201
CTP-543 12 mg BID	152	127

Primary outcome: Number of Participants With Adverse Events as a Measure of Safety

Time frame: 108 weeks. Count of participants. Unit: Participants

Measure	CTP-543 8 mg BID n = 367	CTP-543 12 mg BID n = 273
Value	308	224

Population analysed: All subjects who received at least 1 dose of CTP-543 in this study. Subjects could be counted in both CTP-543 dose groups due to dose changes.

Primary outcome: Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108

Time frame: 108 weeks. Mean (Standard Deviation). Unit: Percentage change

Measure	CTP-543 8 mg BID n = 97	CTP-543 8 mg BID to CTP-543 12 mg BID n = 48	CTP-543 12 mg BID to CTP-543 8 mg BID n = 99
Value	-96.38 (8.790)	-88.57 (18.715)	-90.25 (18.860)

Population analysed: Subjects received ≥1 dose of CTP-543 and ≥1 post-baseline SALT score. The 12 mg BID dose was removed per amended protocol; those on it were reduced to 8 mg BID and are shown in the (12→8 mg BID) group. Max 12 mg BID exposure was 81 weeks; by week 108, no subjects remained on it. Participant Flow reflects planned groups based on prior dose (active) or randomization (placebo). Analysis is based on initial treatment, then first new dose if changed.

Adverse events

Time frame: 108 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CTP-543 8 mg BID	16 of 367 (4.4%)	176 of 367 (48%)	0 of 367
CTP-543 12 mg BID	5 of 273 (1.8%)	127 of 273 (46.5%)	0 of 273

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Alopecia Areata

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

39 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CTP-543 in people with Alopecia Areata, run by Sun Pharmaceutical Industries, Inc. at 39 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Poland, France, Germany, Spain, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events as a Measure of Safety (time frame: 108 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.